Preoperative Intraarterial Chemoembolization Combined With Radiotherpy in Locally Advanced Rectal Cancer

Rectal Cancer Clinical Trial

— PCAR  

Official title:

Multi-center Study of Preoperative Intraarterial Chemoembolization Combined With Radiotherpy in the Management of Locally Advanced Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03601156
• Other study ID #: PCAR
• Status: Recruiting
• Phase: N/A
• Start date: June 2014
• Est. completion date: November 2020

Study information

• Verified date: July 2018
• Source: Third Military Medical University
• Contact: Dong Wang, PH.D.
• Phone: 86-23-68757151
• Email: dongwang64[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compared to postoperative chemotherapy combined with radiotherapy, preoperative chemotherapy combined with radiotherapy shows higher sphincter preservation rate and lower local recurrence rate in locally advanced rectal cancer. The purpose of this study is to evaluate the response and prognosis of intraarterial chemoembolization and intravenous infusion chemotherapy in patients with rectal T3-T4 and/or N+ rectal cancer before operation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: November 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologic or cytologic diagnosis of rectal cancer, Stage IV.

• Males or females between 18 Years to 75 Years.

• No prior cisplatin-based chemotherapy or radiotherapy.

• Performance status of 0~2 on the ECOG criteria.

• Adequate hematologic (Leukocyte count >= 4,000/uL, neutrophil count >= 1,500/uL, hemoglobin >= 10 g/dL, platelets >= 100,000/uL), hepatic (AST & ALT =< upper normal limit(UNL)x1.5, bilirubin level =< UNLx1.5), and renal (creatinine =< UNL x1.5 or creatinine clearance rate =60 ml/min) function.

• Patient can take oral medicine

• Patient compliance that allow adequate follow-up. Informed consent from patient or patient's relative.

Exclusion Criteria:

• Patient with allergic to S-1 or ingredient of Oxaliplatin

• Patient with Peripheral neuropathy

• Diagnosed fibrosis of lung;pulmonary fibrosis or interstitial pneumonia within 28 days.

• Medically uncontrolled serious heart, renal failure, liver failure, hemorrhagic peptic ulcer, paralysis of intestine , ileus, poor controlled diabetes.

• Enrollment in other study.

• Pregnant or breast-feeding.

• Seriously psyche or intelligence problem.

• Inability to comply with protocol or study procedures.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Device:
• intraarterial chemoembolization

• intravenous chemotherapy

Locations

Country	Name	City	State
China	Chongqing Zhongshan Hospital	Chongqing	Chongqing
China	Daping Hospital, Third Military Medical University	Chongqing	Chongqing
China	Jiangjin Central Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological Complete Response (pCR)	Pathological complete response (pCR) was determined on tumor resection specimens after completion of neoadjuvant therapy, and was defined as no evidence of residual invasive and ductal disease in the rectum and lymph nodes	pathologic examination following surgery, at aproximately 9-10 weeks or after preoperative intraarterial chemoembolization plus radiotherpy
Secondary	the Sphincter Preservation Rate		3 month
Secondary	Disease-free survival		Following surgery, 5 years
Secondary	Overall Survival		the first day of treatment to death or last survival confirm date; assesed up to 5 years
Secondary	Down Staging Rate		Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks)
Secondary	Number of Participants with Adverse Events		Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks)
Secondary	Number of Postoperative Complication		Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks)